Hepion Pharmaceuticals Schedules Conference Call to Review Data from Phase 2a ‘AMBITION’ Clinical Trial of CRV431 in NASH
Hepion Pharmaceuticals (NASDAQ:HEPA) announced it will release additional data from its Phase 2a AMBITION NASH clinical trial on September 13, 2021. The trial has already achieved all primary endpoints, and a conference call is scheduled for the same day to discuss the topline results and new data. The company's lead drug candidate, CRV431, is positioned to address non-alcoholic steatohepatitis (NASH) and liver disease. Hepion's proprietary AI platform, AI-POWR™, aims to enhance patient selection and drive clinical development for CRV431 and potentially other indications.
- All primary endpoints were achieved in the Phase 2a AMBITION NASH clinical trial.
- The upcoming data release could enhance investor confidence and interest.
- CRV431 has shown potential in reducing liver fibrosis and has demonstrated antiviral activities in nonclinical studies.
- Uncertainties regarding regulatory approvals and potential delays in clinical trials.
- Reliance on third-party reimbursements and competitive market pressures could hinder success.
EDISON, N.J., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and liver disease, today announced that it expects to release additional data from its Phase 2a ‘AMBITION’ NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial.
Hepion is pleased to invite all interested parties to participate in a conference call and webcast at 8:30 a.m. ET on September 13, during which the previously disclosed AMBITION topline results, as well as the additional new data, will be discussed.
To participate telephonically, please dial (855) 493-3481 (U.S.) or (929) 517-0949 (international), conference ID 3568976, approximately 10 minutes prior to the start time. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the “Events” page of the “Investors” section at www.hepionpharma.com. An archive of the webcast will be available for approximately 90 days following the conclusion of the conference call.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
FAQ
What are the primary endpoints achieved in the Phase 2a AMBITION clinical trial for HEPA?
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What is CRV431 and its significance for liver disease treatment?
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